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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06383468
Other study ID # AK120-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 30, 2024
Est. completion date January 30, 2026

Study information

Verified date April 2024
Source Akeso
Contact Guoqin Wang
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.


Description:

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.


Recruitment information / eligibility

Status Recruiting
Enrollment 420
Est. completion date January 30, 2026
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Male or female subjects aged =18=75 years old. 2. Atopic dermatitis (AD) diagnosed at least 1 year before screening. 3. Subject with eczema area and severity index (EASI) score =16, Investigator Global Assessment (IGA) score= 3, Body Surface Area (BSA) score = 10% at screening and baseline. 4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable Exclusion Criteria: 1. Acute onset of AD within the first 4 weeks of randomization. 2. Have participated in any clinical research on AK120 in the past 3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization. 4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer) 5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period. 6. Received allergen specific immunotherapy within the 3 months before randomization. 7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK120
300mg Q2W subcutaneous injection thereafter until week 50.

Locations

Country Name City State
China Baoji Central Hospital Baoji Shanxi
China Beijing Friendship Hospital Capital Medical University Beijing Beijing
China Beijing Luhe Hospital Affiliated to Capital Medical University Beijing Beijing
China Beijing Tongren Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Jiangsu
China The First Bethune Hospital of Jilin University Changchun Jilin
China Changde First People's Hospital Changde Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China Changzhou First People's Hospital Changzhou Jiangsu
China Chengde Medical College Affiliated Hospital Chengde Hebei
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Chongqing Three Gorges Medical College Affiliated People's Hospital Chongqing Chongqing
China Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China The First Affiliated Hospital of Gannan Medical College Ganzhou Jiangxi
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital Guangzhou Guangdong
China Southern Medical University Southern Hospital Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
China The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
China Hainan General Hospital Haikou Hainan
China Hainan Provincial Fifth People's Hospital Haikou Hainan
China The First Affiliated Hospital of Hainan Medical College Haikou Hainan
China Hangzhou First People's Hospital Hangzhou Zhejiang
China Hangzhou Third People's Hospital Hangzhou Zhejiang
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Harbin Medical University Affiliated Second Hospital Harbin Heilongjiang
China Heilongjiang Provincial Hospital Harbin Heilongjiang
China The First Affiliated Hospital of South China University Hengyang Hunan
China Inner Mongolia Medical University Affiliated Hospital Hohhot Inner Mongolia
China Jiaxing First People's Hospital Jiaxing Zhejiang
China Shandong Provincial Dermatology Hospital Jinan Shandong
China Shandong University Qilu Hospital Jinan Shandong
China The First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China The Second Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
China Ningbo First Hospital Ningbo Zhejiang
China Ningbo Huamei Hospital, University of Chinese Academy of Sciences Ningbo Zhejiang
China Panjin Liaoyou Gemstone Flower Hospital Panjin Liaoning
China Qingdao Municipal Hospital Qingdao Shandong
China Shanghai Dermatology Hospital Shanghai Shanghai
China Yuebei People's hospital, Guangdong, China Shaoguan Guangdong
China Shenyang Integrated Traditional Chinese and Western Medicine Hospital Shenyang Liaoning
China Zhongyi Northeast International Hospital Shenyang Liaoning
China Shunde Hospital of Southern Medical University Shunde Guangdong
China Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital Tianjin Tianjin
China Xinjiang Uygur Autonomous Region People's Hospital Urumqi Xinjiang
China Wenzhou Medical University First Affiliated Hospital Wenzhou Zhejiang
China Renmin Hospital of Wuhan University Hubei General Hospital Wuhan Hubei
China Tongji Hospital Wuhan Hubei
China The Second Affiliated Hospital of Xiamen Medical College Xiamen Fujian
China The Second Affiliated Hospital of Xingtai Medical College Xingtai Hebei
China Yancheng First People's Hospital Yancheng Jiangsu
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Guangdong Medical University Affiliated Hospital Zhanjiang Guangdong
China Jiangsu University Affiliated Hospital Zhenjiang Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16. at week 16
Secondary Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16. at week 16
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